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Effectiveness and safety of early lumbar cistern drainage in the treatment of ventricular hemorrhage: A multicenter, randomized controlled study

Efficacy and safety of early lumbar cistern drainage combined with external ventricular drainage and intrathecal injection of urokinase in the treatment of ventricular hemorrhage: A multicenter randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123877
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraventricular hemorrhage

Interventions

Control group:External ventricular drainage combined with intrathecal injection of urokinase
Intervention group:Lumbar cistern drainage + external ventricular drainage combined with intrathecal injection of urokinase

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 85 years old, regardless of gender; 2. Patients with cerebral hemorrhage who have had their first episode of cerebral hemorrhage, with intraventricular hemorrhage (hemorrhage in the third and/or fourth ventricle) confirmed by CT or other imaging methods, and have undergone external ventricular drainage; 3. The initial CT scan shows that the volume of cerebral hemorrhage is less than 30 mL. The patient's symptoms are stable before randomization without further deterioration of the; 4. External ventricular puncture and drainage are performed within 48 hours after the onset of the disease; 5. Randomization is completed within 24 hours after external ventricular drainage; 6. The modified Rankin Scale (mRS) score before the onset of disease is the 0 (no symptoms at all) or 1 (mild symptoms that do not affect daily work); 7. The subject or their guardian signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Suspected (unless excluded by angiography or MRA/MRI) or untreated ruptured cerebral aneurysms, intracranial arteriovenous malformations (AVM) or tumors. Treatment of existing aneurysms or AVMs must be completed at least 3 months before the current; onset 2. Presence of choroid plexus vascular malformations or moyamoya disease; 3. Long - term use of anticoagulants, persistent coagulation disorders or allergy to urokinase; 4. Platelet count 1.4; 5. Absoluteindications for contra lumbar cistern drainage or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site); 6. Subtentorial hemorrhage with a blood volume >= 10 mL; 7. Thalamic hemorrhage with a blood volume >= 10 mL, or by obvious accompanied extension to the midbrain, third nerve palsy or fixed and non - reactive dilated pupils; 8. Limb hemiplegia with muscle strength of grade 0 or 1; 9. Active bleeding in other parts such as the gastrointestinal tract, genitourinary tract or tract respiratory; 10. Multiple symptoms of congestion, ecchymosis, purpura, etc. in superficial parts, indicating bleeding or bleeding tendency; 11. Expected lifespan of less than 6 months due to other reasons; 12. Other accompanying severe and difficult - to - treat diseases; 13. Pregnant women; 14. Participation in another interventional clinical trial within 30 days before randomization; 15. Other reasons judged by the researcher as unfit for participation in the study.

Design outcomes

Primary

MeasureTime frame
The ratio (%) of patients with a modified Rankin Scale score of 0 - 3 points at 180 days after onset.;

Secondary

MeasureTime frame
The ratio (%) of patients with a modified Rankin Scale (mRS) score of 0 - 3 at 90 days after onset.;The ratio (%) of patients with a GOS score of 4 - 5 at 180 days after onset .;The ratio (%) of patients with a modified Rankin Scale score of 0 - 2 points at 180 days after onset.;The ratio (%) of patients with a modified Rankin Scale score of 0 - 2 points at 90 days after onset.;Sequential changes in mRS scores at 180 days after onset;EQ-5D scale score at 180 days after onset;The ratio (%) of patients with a Barthel index of 75 - 100 points at 180 days after onset .;Hydrocephalus (%);Length of hospital stay (d);Total hospitalization expenses;

Countries

China

Contacts

Public ContactLv Shigang

The Second Affiliated Hospital of Nanchang University

lvsg1982@163.com+86 159 7904 1384

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026